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Heart Rate Sensing and Response in Persons With Anorexia Nervosa

2016年12月30日 更新者:Duke University
There are two major goals of this investigation. First, to develop pilot data to justify a larger randomized clinical trial of an intervention designed to train interoceptive signals (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the investigators will determine whether persons with AN have similar or different IS and IR for heart rate while exercising as compared to age and gender matched controls.

研究概览

详细说明

The purpose of this pilot investigation is to assess AN interoceptive sensitivity and responsivity as it pertains to heart rate during exercise. Thirty adults, 18 years and older will be recruited for a cross-sectional comparison of IS and IR in the context of exercise.

研究类型

介入性

注册 (实际的)

18

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27705
        • Duke Medicine - Duke Molecular Physiology Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria: Study participants will include adults with anorexia spectrum disorders and healthy age and gender matched controls. There will be two control groups, one that includes regularly exercising age and gender matched persons and one where controls do not engage in regular exercise.

For those with AN, the following INCLUSION criteria must be met:

  • Age ≥ 18 years old
  • BMI 25 kg/m2 or less
  • Diagnosis of anorexia spectrum disorder
  • Medications: Stable use of all medications ≥ three months

For age and gender matched controls, the following INCLUSION criteria must be met:

  • Age ≥ 18 years old
  • BMI 25 kg/m2 or less
  • No diagnosis of anorexia spectrum disorder
  • Medications: Stable use of all medications ≥ three months
  • Age (+/- 2 years) and gender matched to study participant

Exclusion Criteria:

  • History of diabetes, heart disease or taking medications for those conditions
  • History of hypertension (high blood pressure) not controlled with medication
  • Orthopedic limitations, musculoskeletal disease and/or injury
  • Inability to consent
  • Lack of transportation to the Duke Center for Living campus

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Anorexia Nervosa (AN)
Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months.
All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.
实验性的:Matched Controls
No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Also age (+/- 2 years) and gender matched to AN study participant and exercise regularly.
All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.
实验性的:Healthy Controls
No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly.
All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training
大体时间:Baseline only
One exercise training session
Baseline only

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nancy L Zucker, PhD、Director, Duke Center for Eating Disorders

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年3月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2015年10月15日

首先提交符合 QC 标准的

2015年10月15日

首次发布 (估计)

2015年10月19日

研究记录更新

最后更新发布 (估计)

2017年1月2日

上次提交的符合 QC 标准的更新

2016年12月30日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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